The Applied Tissue Technologies PWD™ Platform Wound Dressing is intended to be used in conjunction with the Invia Motion Negative Pressure Wound Therapy (NPWT) system and is indicated in patients who would benefit from a suction device (NPWT) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as: diabetic, pressure and venous insufficiencies), flaps and grafts.

Device Description

The Applied Tissue Technologies PWD™ Platform Wound Dressing is a single use device. Its transparency permits the healthcare practitioner to observe the progress of the wound healing without removing the wound dressing. There is an access port to administer negative pressure wound therapy. The PWD is intended to be used for a maximum of 3 days. Therapy duration may be less than indicated if clinical practice or other factors require more frequent dressing changes. The PWD will be marketed in four different shapes and sizes, all having the same intended use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Applied Tissue Technologies PWD™ Platform Wound Dressing. This document asserts substantial equivalence to a predicate device, the Medela Ag Invia Foam Dressing Kit (K170088), rather than detailing an independent study to prove specific acceptance criteria for a new AI/ML device.

Therefore, many of the requested categories are not applicable to the information contained in this FDA submission. The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through performance data and a comparison of technological characteristics.

Here's an breakdown based on the provided text, highlighting what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (e.g., sensitivity, specificity, or improvement in a specific clinical outcome). Instead, it relies on demonstrating that the device's technical performance characteristics are acceptable and comparable to a predicate device.

Performance Metric	Acceptance Criteria (Implied by Comparison)	Reported Device Performance (PWD™ Platform Wound Dressing)
Device Vapor Transmission	Acceptable	Acceptable test results
Ability to Maintain Negative Pressure	Acceptable	Acceptable test results
Ability to Remove Exudate	Acceptable	Acceptable test results
Biocompatibility	According to ISO 10993 standard series	Acceptable test results
Maximum Duration of a single dressing	72 Hours (Same as predicate)	72 Hours
Negative Pressure to the wound surfacerequirements in mmHg	125 mmHg (Predicate)	80 mmHg (nominal) +/- 20mmHG to the wound surface. Noted as a nominal recommended setting, pump settings range from -40 to -175. This difference does not raise new questions of safety.
Multiple Shapes for Wound Sizes up to 400cc	240 - 2700cc (Predicate)	400cc (within the range of the predicate device)
Dressing Configuration	Similar to predicate (Clear polyurethane occlusive drape dressing with foam insert)	Clear polyurethane embossed occlusive drape with tubing. (Similar materials and configuration; embossed layer allows fluid transfer instead of foam, deemed not to raise new questions of safety)
Access Port	Same as predicate	For attachment to the negative pressure pump; for removal of fluids.
Collection Pack	Same as predicate	PWD tubing connected to Medela Invia Motion canister/tubing set for fluid collection.
Pump	Same as predicate	To be used with the Medela Invia® Motion™ Negative Pressure Wound Therapy System.
How Supplied	Same as predicate	Sterile Single Use Only
Tissue Contact Materials	Similar to predicate	Polymers and Adhesive (Differences do not introduce new questions of safety)
Additives - antimicrobial, animal origin	No (Same as predicate)	No
Sterilization	Eto (Same as predicate)	Eto

2. Sample size used for the test set and the data provenance

The document mentions "Bench testing" and "Biocompatibility testing" but does not provide details on the sample sizes used for these tests. The data provenance is laboratory testing, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the study involves bench testing and biocompatibility, not clinical evaluation requiring expert ground truth for patient outcomes or diagnostic accuracy.

4. Adjudication method for the test set

Not applicable as it's not a clinical study with an adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a wound dressing, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a wound dressing, not an AI/ML algorithm.

7. The type of ground truth used

For the bench tests (vapor transmission, negative pressure maintenance, exudate removal), the "ground truth" would be the measured physical properties satisfying engineering specifications. For biocompatibility, the ground truth is adherence to ISO 10993 standards and accepted biological safety profiles for the materials. This is not "expert consensus, pathology, or outcomes data."

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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January 11, 2019

Applied Tissue Technologies LLC % Michele Lucey Regulatory Affairs Manager Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255

Re: K182409

Trade/Device Name: Applied Tissue Technologies PWD™ Platform Wound Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: December 7, 2018 Received: December 12, 2018

Dear Michele Lucey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kimberly Ferlin -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182409

Device Name

Applied Tissue Technologies PWD™ Platform Wound Dressing

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Submitter Information

Submitters' Name:	Applied Tissue Technologies LLC
Address:	99 Derby Street, Suite 200Hingham, MA 02043
Telephone:	781-366-3848
Contact Person:	Michele Lucey
Telephone:	603-748-1374
Date Prepared:	January 11, 2019
Device Trade Name:	Applied Tissue TechnologiesPWD™ Platform Wound Dressing
Classification:	Class II
Product Code(s):	OMP
Regulation Number(s):	21 CFR 878-4780 Powered Suction Pump
Predicate Device:	Medela Ag Invia Foam Dressing Kit,K170088

Intended Use:

Device Description/Technological Characteristics:

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The PWD will be marketed in four different shapes and sizes, all having the same intended use. The four sizes are identified as follows.

PWDTM Platform Wound Dressing
Description	Catalog/REF #
1" Round	AT1070-01
2" Round	AT1071-01
3" Round	AT1072-01
1" x 3" Oblong	AT1073-01

Performance Data:

Bench testing of the PWD™ Platform Wound Dressing was performed to evaluate device vapor transmission characteristics, ability to maintain negative pressure, and the ability to remove exudate. Biocompatibility testing was conducted according to the ISO 10993 standard series. Test results of all nonclinical testing were acceptable and demonstrate that the subject device is substantially equivalent to the predicate device

Substantial Equivalence:

The following chart provides the evidence to support the claim for substantial equivalence:

Substantial Equivalence Comparison Chart
Feature / Specification	PWDTMPlatform WoundDressing	Invia Foam Dressing Kit(Medela Ag,)	Comparison
Regulatory Clearance/Approval Reference	K182409	K170088	N/A
Product Code	OMP	OMP	Same
Regulation Number	21 CFR 878.4780	21 CFR 878.4780	Same
Regulation Name	Powered Suction Pump(accessory)	Powered Suction Pump(accessory)	Same
Where used(environment)	The Negative PressureWound Therapy Systemis suitable for use in bothhospital and homecaresettings.	The Negative PressureWound Therapy System issuitable for use inboth hospital andhomecare settings.	Same
Maximum Duration ofa single dressing	72 Hours	72 Hours	Same
Negative Pressure tothe wound surfacerequirements in mmHg	80 mmHg (nominal)+/- 20mmHG to thewound surface	125 mmHg to the woundsurface	This constitutes anominalrecommendedsetting, pumpsettings rangefrom -40 to -175.This differencein recommendednominal setting.
Substantial Equivalence Comparison Chart
Feature / Specification	PWDTMPlatform WoundDressing	Invia Foam Dressing Kit(Medela Ag,)	Comparison
			does not rangenew questions ofsafety.
Multiple Shapes forWound Sizes up to400cc (Surface Area xdepth)	400cc	240 - 2700c	PWD is withinthe range of thepredicatedevice.
DressingConfiguration	Clear polyurethaneembossed occlusive drapewith tubing	Clear polyurethaneocclusive drape dressingwith foam insert negativepressure/instillation tubing –dressing is cut to size	Similarmaterials andconfiguration,the PWD uses aembossed layerto allow forfluid transfer,the predicateuses afoam. Thisdifference doesnot raise newquestions ofsafety.
Access Port	For attachment to thenegative pressure pump.For removal of fluids.	For attachment to thenegative pressure pump.For removal of fluids	Same.
Collection Pack	The PWD tubing isconnected to the MedelaInvia Motioncanister/tubing set duringnegative pressure woundtherapy for collection offluids. The fluids areremoved from the woundsite and secured withinthe cannister.	The Invia Foam DressingTubing is connected to theMedela Invia Motioncanister/tubing set duringnegative pressure woundtherapy for collection offluids. The fluids areremoved from the woundsite and secured within thecannister	Same.
Pump	To be used with theMedela Invia®Motion™ NegativePressure WoundTherapy System	To be used with the MedelaInvia® Motion™ NegativePressure Wound TherapySystem	Same
How Supplied	PWD is Sterile SingleUse Only	Dressing is SterileSingle Use Only	Same
Substantial Equivalence Comparison Chart
Feature / Specification	PWDTMPlatform WoundDressing	Invia Foam Dressing Kit(Medela Ag,)	Comparison
Tissue ContactMaterials	Polymers and Adhesive	Polymers Adhesive anddressing	Similar,differences donot introducenew questions ofsafety
Additives - antimicrobial,animal origin	No	No	Same
Sterilization	Eto	Eto	Same

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The PWD™ Platform Wound Dressing is substantially equivalent to the predicate device, the Invia Foam Dressing Kit (K170088) and does not raise different questions of safety and effectiveness.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.